Takeda : New Drug Application in the U.S. for Alogliptin (SYR-322) / ACTOS(R) (pioglitazone HCl) for the Treatment of Type 2 Diabetes

September 24, 2008 - Takeda Pharmaceutical Company Limited (Takeda) announced that its wholly owned subsidiary, Takeda Global Research & Development Center Inc. (U.S.), submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for marketing approval of alogliptin (SYR-322) and ACTOS^® (pioglitazone HCl) (“alogliptin/ACTOS”) in a single tablet for the treatment of type 2 diabetes.

Alogliptin was discovered by Takeda’s wholly owned subsidiary, Takeda San Diego, Inc. and is a member of the DPP-4 inhibitors class, which are newer oral agents for the treatment of type 2 diabetes. DPP-4 inihibitors slow the inactivation of incretin hormones GLP-1 (glucagon-like peptide-1) and GIP (glucose-dependent insulinotropic peptide). The incretins play a major role in regulating blood glucose levels and have the potential to improve pancreatic beta-cell function. GLP-1 and GIP are produced by the digestive tract in response to food and regulate glucose balance, primarily by stimulating glucose-dependent insulin secretion. In addition, GLP-1 suppresses pancreatic glucagon secretion and subsequent liver glucose production, enhances glucose disposal, slows gastric emptying, and elicits satiety, a feeling of fullness. Takeda is the originator of the thiazolidinedione (TZD) class of oral anti-diabetes medications. ACTOS is a TZD that directly targets insulin resistance, a condition in which the body does not efficiently use the insulin it produces to control blood glucose levels... Takeda's Press Release -

Sirtris : EXCLUSIVE LICENSE TO HARVARD’S SIRT3-BASED INTELLECTUAL PROPERTY

September 16, 2008 – Sirtris, a GSK Company focused on discovering and developing small molecule drugs to treat diseases of aging such as Type 2 Diabetes, announced that it has completed an agreement with Harvard University to exclusively license two patent applications covering SIRT3-based methods of treatments and assays.

Sirtuins are a family of enzymes which regulate the aging process and have been the subject of extensive research. While SIRT1 — the founding member of this class of enzymes — is currently the most studied in the group, considerable research is underway on other members in this family, SIRTs 2-7. A study by Sirtris Scientific Advisory Board members and Harvard University scientists, published in the journal Cell in September 2007, showed for the first time that activation of SIRT3 and SIRT4 protects against cell damage. The findings further validated sirtuins as important targets for treating diseases of aging. The two patent applications being exclusively licensed from Harvard include assays useful for identifying SIRT3 activators for diseases of aging... Sirtris' Press Release -

Oramed Pharmaceuticals : GLP1-Analog Program, Based on its Proprietary Drug Delivery Platform

September 16, 2008 – Oramed Pharmaceuticals, Inc. (OTCBB: ORMP.OB), a developer of oral drug delivery systems, announced that it has launched pre-clinical trials of ORMD 0901, a GLP1-analog.
ORMD 0901 belongs to the Incretin family of drugs which helps to manage diabetes, including reduction in blood glucose levels and inhibiting glucagon secretion.
Incretins have been cited in causing regeneration of pancreatic insulin secreting cells, and in tissue protective properties including protection of the heart. GLP1 and analogs are associated with gradual weight loss, which is very desirable in diabetes patients... [PDF] Oramed's Press Release -

MannKind & Pfizer : Collaboration for Certain Exubera Patients to Transition to MannKind's Inhaled Insulin Therapy

Sep 16, 2008 - MannKind Corporation (Nasdaq: MNKD) and Pfizer Inc (NYSE: PFE) announced that MannKind will transition certain Exubera patients with a continuing need for inhaled insulin to MannKind's inhaled insulin product, Technosphere(R) Insulin. Technosphere Insulin is an investigational product that has recently completed Phase 3 clinical trials.

In October 2007, Pfizer announced that it would stop marketing Exubera (insulin human (rDNA origin)) Inhalation Powder because it did not meet customers' needs or Pfizer's financial expectations. Since that time, Exubera patients have been transitioning to other diabetes therapies, although there remains a small number of patients with a continuing medical need for inhaled insulin. Pfizer began discussions with MannKind to give these patients access to Technosphere Insulin. Pfizer will reimburse some of MannKind's costs relating to the transition of patients... Pfizer's Press Release - MannKind's Press Release -

MannKind : Positive Data from a Phase 3 Clinical Study of Technosphere Insulin in Type 1 Diabetes

Sept. 16, 2008 - MannKind Corporation (Nasdaq: MNKD) released preliminary top-line results from a Phase 3 clinical study of the Technosphere(R) Insulin System in patients with type 1 diabetes (Study 009). This study compared the safety and efficacy of prandial inhalations of Technosphere Insulin (the TI group) versus prandial subcutaneous injections of insulin aspart (the comparator group). Both groups also received daily subcutaneous injections of a basal insulin (insulin glargine).

Study Highlights
Technosphere Insulin, compared to a rapid-acting insulin analog, showed:

• Comparable reductions in A1C levels
• Comparable numbers of patients reaching pre-defined A1C goals
• Superior fasting blood glucose levels
• Better early post-prandial glucose control
• Fewer patients experiencing hypoglycemic events
• Weight loss versus weight gain
• No adverse effects on pulmonary function... MannKind's Press Release -

DiaMedica : First Patient in Phase IIa Clinical Trial for DM-99

August 11, 2008 – DiaMedica Inc. (TSX-V:DMA), a drug discovery and clinical development company focused on a novel approach to treating type 2 diabetes, announces enrollment of the first patient in the phase II proof of concept clinical trial with DM-99, the Company’s third drug candidate to enter phase II human trials.

The single-blinded clinical trial being conducted in the European Union, will demonstrate DM-99’s effectiveness at controlling blood glucose levels in 40 type 2 diabetes patients with HbA1c levels over 7.5%, after they have consumed a standardized meal. Change in insulin and/or glucose levels is the study’s primary endpoint. Each patient will be tested for both the effects of treatment with DM-99 as well as a placebo, and will therefore serve as their own control in this cross over study. Results are expected at the end of 2008... DiaMedica's Press Release -

Diamyd Medical : NTDDS Technology Effective against Diabetes Pain

September 1, 2008 - Diamyd Medical (Pink Sheets:DMYDY)(STO:DIAMB) reports that its Nerve Targeting Drug Delivery System (NTDDS) expressing enkephalin, is effective in preclinical models of diabetes pain - Dr. David Fink, published in the scientific journal “Journal of Neuroscience” that Diamyd Medical’s proprietary NTDDS platform, expressing enkephalin, effectively relieves pain due to diabetes in animals. The NTDDS platform allows focal delivery of the human enkephalin gene directly to nerves experiencing pain.

”These new data indicate that not only is the NTDDS platform with enkephalin effective at reducing pain, it reverses the root cause of diabetes related pain. This means that the approach is not just pain relief, but local pain prevention”, says Darren Wolfe, President of Diamyd Inc.

Elisabeth Lindner, President and CEO of Diamyd Medical, states “We have positioned Diamyd Medical as a diabetes company. These exciting results give us the opportunity to expand our product portfolio to include a third diabetes related product, NP2”... Diamyd's Press Release -

CV Therapeutics : Phase 1 Clinical Trial of CVT-3619, a Novel Potential Treatment for Cardiometabolic Diseases

Sept. 2 , 2008 - CV Therapeutics, Inc. (Nasdaq: CVTX) announced that the company has enrolled the first patient in a Phase 1 trial of CVT-3619, a novel oral compound for potential treatment of cardiometabolic diseases. The U.S. Food and Drug Administration recently accepted the Company's investigational new drug application for CVT-3619, a partial A1 adenosine receptor agonist.

This Phase 1 trial will assess the safety and pharmacokinetic profile of CVT-3619 in healthy volunteers. The Phase 1 program will provide early data on the compound's potential effects on circulating levels of free fatty acids, which are associated with high blood lipid levels, insulin resistance and other cardiometabolic risk factors...

..."CVT-3619 represents a first-in-class agent that appears to inhibit the release of free fatty acids from fat cells and has the potential to meet a tremendous unmet need by potentially treating both dyslipidemia and diabetes. We look forward to the clinical development of this innovative medication... CV Therapeutics' Press Release -

Roche NimbleGen CGH Arrays Enable Detection of the Genomic Disorder Resulting in Diabetes

July 30, 2008 — Chromosomal rearrangements leading to genomic disorders are often mediated by low-copy repeat regions of the genome (e.g. segmental duplications). Roche NimbleGen CGH arrays offer expanded probe coverage in these regions. Using this technique, the authors of a recently published paper¹ identified a recurrent reciprocal genomic rearrangement of chromosomal region 17q12 in fetal samples with congenital anomalies that is also associated with pediatric renal disease and epilepsy. The results emphasize the importance of evaluating de novo structural variation events in pediatric diseases other than mental retardation and the importance of duplication architecture as a predisposing factor for disease.

Genomic disorders result from nonallelic homologous recombination (NAHR) between low-copy repeat regions of the genome and occur in approximately 1 in 1,000 live births. The phenotypes of many of these known genomic disorders include developmental delay and mental retardation. Therefore, screening for novel genomic disorders has largely focused on patients with cognitive disability and/or peripheral nervous system defects... Roche NimbleGen's Press Release -